Regulatory Affairs Manager (Salaberry-de-Valleyfield)

Regulatory Affairs Manager (Salaberry-de-Valleyfield)

19 Apr
|
Lallemand
|
Salaberry-de-Valleyfield

19 Apr

Lallemand

Salaberry-de-Valleyfield

Main Functions

Ensure regulatory follow-up for products, processes, or technologies under development;

Develop and implement regulatory strategies;

Prepare, submit, and maintain regulatory dossiers;

Ensure product compliance with applicable regulatory requirements (Canada, United States, and other international markets);

Serve as the main point of contact with regulatory authorities and respond to information requests;

Monitor regulatory developments to anticipate changes and their impact on company activities;

Collaborate closely with the Scientific Director and internal teams to ensure compliance and address regulatory issues;

Participate in client audits and regulatory inspections;

Ensure proper archiving of data and documentation in accordance with internal policies and applicable requirements;

Advise internal teams on regulatory requirements;





Address client and supplier requests regarding regulatory compliance and qualification.

Technical skills Required

Bachelor’s degree in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or a related field.

Excellent command of English (reading, writing, and comprehension).

Positive proficiency with computer tools.

Personal abilities Required

Excellent communication skills.

Autonomy, resourcefulness, and initiative.

General criteria Required

Minimum of 3 years of experience in the pharmaceutical industry or 5 years in the food industry.

Knowledge of Good Manufacturing Practices (GMP) and pharmaceutical and food regulations (FDA, Health Canada, EMA, ICH, EC).

An asset

Knowledge of FSSC 22000 standard.

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📌 Regulatory Affairs Manager (Salaberry-de-Valleyfield)
🏢 Lallemand
📍 Salaberry-de-Valleyfield

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